Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

FDES105B Body Pads (P105B-2)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130723,K130723,K130723

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

56f7184a-d8e2-473c-8771-6d7b30a0851e

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

10311917176403

Quantity per Package

120

Contains DI Package

00311917176406

Package Discontinue Date

October 19, 2016

Package Status

Not in Commercial Distribution

Package Type

Case